text
stringlengths 0
197k
|
|---|
The absorption of BAY2927088 into the blood is dependent on the amount of acid present in the stomach. Esomeprazole is a medicine which is used in the treatment of heartburn and excessive acid in the stomach. Both food and esomeprazole may change the amount of acid present in the stomach. |
The main purpose of this study is to find out how food and esomeprazole may affect the absorption of BAY2927088 into the blood of healthy participants. For this, researchers will measure the levels of BAY2927088 in participants' blood when it is given with or without food as well as with or without esomeprazole. Researchers will then calculate the following: |
* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time |
* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood |
The study will have 4 treatment periods: |
- Periods 1 to 3 (Day 1 to Day 9): All participants will take BAY2927088 with a low-fat meal, with a high-fat meal, and on an empty stomach, but in a different order, over the 3 study periods. Each period will last for 3 days and BAY2927088 will be given on the first day of each period. |
On Day 9, participants will take esomeprazole on an empty stomach. |
- Period 4 (Day 10 to Day 14): On Days 10 and 11, participants will take esomeprazole on an empty stomach. On Day 12, participants will take esomeprazole on an empty stomach. After 1 and a half hours, participants will take low-fat meal and BAY2927088. |
On Day 13, participants will take esomeprazole on an empty stomach. |
Participants will be in this study for about 8 weeks with 3 visits to the study clinic. |
Participants will visit the study clinic: |
* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study |
* once on the day before the treatment starts and will stay in the clinic until Day 14 of the treatment |
* once, 7 to 10 days after last dose of BAY2927088, for a health check-up |
During the study, the doctors and their study team will: |
* do physical examinations |
* collect blood samples from the participants to measure the levels of BAY2927088 |
* check participants' health by performing tests, such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) |
* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective of whether they think it is related or not to the study treatment. conditions: Advanced Non-small Cell Lung Cancer conditions: EGFR Mutation conditions: HER2 Mutation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 21 type: ESTIMATED name: BAY2927088 name: Esomeprazole name: Food measure: Cmax for BAY2927088 in plasma measure: AUC for BAY2927088 in plasma measure: Number of participants with treatment-emergent adverse events (TEAEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: PAREXEL International, Baltimore status: RECRUITING city: Baltimore state: Maryland zip: 21225 country: United States lat: 39.29038 lon: -76.61219 hasResults: False |
<|newrecord|> nctId: NCT06378645 id: 2023-01682 briefTitle: Effect of Propofol vs. Sevoflurane on Erections During Narcosis In Transurethral Surgery acronym: PENIS overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-22 date: 2024-04-22 name: Etienne Xavier Keller class: OTHER briefSummary: Penile erection is an unwanted event in transurethral (through the urethra) surgeries, which may be associated with adverse outcomes such as impaired access, prolonged operation time, the need to abort the operation, or the necessity for ancillary measures to achieve penile flaccidity, such as the injection of certain medications directly into the penis. |
To reduce greenhouse gas emissions, the primary use of propofol instead of gaseous agents is being recommended for general anesthesia. Whether propofol may be associated with an increased or decreased rate of unwanted intraoperative penile erection compared to other anesthetic agents is not known. More generally, there are no high-quality studies available to evaluate the impact of the type of general anesthesia on the risk of unwanted penile erections during surgery. |
This study aims to determine whether general anesthesia with propofol is more likely to cause intraoperative erections compared to sevoflurane during transurethral operations. conditions: Erection; Incomplete studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The authorized study nurse will hand the upcoming envelope with the treatment allocation to the anesthesiologist. The patient and the urologists (who is measuring the outcome) will not know which form of general anesthesia will be performed. Herewith, blankets in the operating room will hide installations used by the anesthesiologists to prevent the urologists witnessing the assigned narcosis form. Before the surgical sign-out, while still scrubbed in and with the patient under anesthesia, the anesthesiologists will ask the urologists about the outcome questionnaire. Together, they will fill in the paper case report form (CRF). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: General Anesthesia: Propofol name: General Anesthesia: Sevoflurane measure: Intraoperative Penile Erection measure: Prolongation of the surgery measure: Change in operative strategy measure: Adaptions of instruments or approaches measure: Altered operative outcome measure: Necessity for a drug application to decrease penile tumescence measure: Complications arisen sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich status: RECRUITING city: Zürich zip: 8091 country: Switzerland name: Etienne X Keller, Ass Prof, MD role: CONTACT phone: +41 44 255 54 40 email: [email protected] lat: 47.36667 lon: 8.54999 hasResults: False |
<|newrecord|> nctId: NCT06378632 id: CLN0011 DETECT-HF briefTitle: AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM acronym: DETECT-HF overallStatus: RECRUITING date: 2022-02-11 date: 2024-07-15 date: 2024-12-01 date: 2024-04-22 date: 2024-04-22 name: Cordio Medical class: INDUSTRY briefSummary: Study Design: |
This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Hearo App measure: Heart Failure Events (HFEs) sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eastern Shore Research Institute status: RECRUITING city: Fairhope state: Alabama zip: 36532 country: United States name: Jessica Huckleberry, SC role: CONTACT phone: 251-990-1920 email: [email protected] name: Michael Pursley, MD role: PRINCIPAL_INVESTIGATOR lat: 30.52297 lon: -87.90333 facility: UC San Diego Health status: RECRUITING city: La Jolla state: California zip: 92037 country: United States name: Joshua Gillman, SC role: CONTACT phone: 858-246-2511 email: [email protected] name: Nicholas Wettersten, MD role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: VA Loma Linda Healthcare System status: RECRUITING city: Loma Linda state: California zip: 92357 country: United States name: Vicki Simpson, SC role: CONTACT phone: 909-593-6361 email: [email protected] name: Jay Patel, MD role: PRINCIPAL_INVESTIGATOR lat: 34.04835 lon: -117.26115 facility: VA San Diego status: RECRUITING city: San Diego state: California zip: 92161 country: United States name: Jonathan Narita, SC role: CONTACT phone: 858-642-3512 email: [email protected] name: Nancy Gardetto, MD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94117 country: United States name: Priscilla Zhang, SC role: CONTACT phone: 415-514-7903 email: [email protected] name: Liviu Klein, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Kaiser Permanente San Francisco status: RECRUITING city: San Francisco state: California zip: 94118 country: United States name: Priscilla Chung, SC role: CONTACT phone: 415-833-3480 email: [email protected] name: Jana Svetlichanaya, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Nature Coast Clinical Research status: RECRUITING city: Crystal River state: Florida zip: 34429 country: United States name: Nina Smith, SC role: CONTACT phone: 352-563-1865 email: [email protected] name: Susan Pasupuleti, MD role: PRINCIPAL_INVESTIGATOR lat: 28.90248 lon: -82.5926 facility: Jacksonville Center for Clinical Research status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States name: Taylor Johnson, SC role: CONTACT phone: 904-730-0101 email: [email protected] name: Michael Koren, MD role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Amavita Clinical Research status: RECRUITING city: Miami state: Florida zip: 33137 country: United States name: Nereisy Alonso, SC role: CONTACT phone: 786-703-5941 email: [email protected] name: Pedro Martinez Clark, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Advance Medical Research Services Corp (AMRS) status: RECRUITING city: Miami state: Florida zip: 33173 country: United States name: Adam Rachid, SC role: CONTACT phone: 305-928-8845 email: [email protected] name: Yordan Orive Gomez, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Baptist Health (Miami Cardiac & Vascular Institute) status: RECRUITING city: Miami state: Florida zip: 33173 country: United States name: Margie Mckercher, SC role: CONTACT phone: 786-595-8075 email: [email protected] name: Sandra Chaparro, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Comprehensive Medical & Research Center status: RECRUITING city: Plantation state: Florida zip: 33317 country: United States name: Wilmer Santiesteban Garcia, SC role: CONTACT phone: 954-368-3529 email: [email protected] name: William Korey, MD role: PRINCIPAL_INVESTIGATOR lat: 26.13421 lon: -80.23184 facility: St. Johns Center for Clinical Research status: RECRUITING city: Saint Augustine state: Florida zip: 32086 country: United States name: Valerie Hayes, SC role: CONTACT phone: 904-209-0043 email: [email protected] name: Ameeth Vedre, MD role: PRINCIPAL_INVESTIGATOR lat: 29.89469 lon: -81.31452 facility: Tampa General Hospital status: RECRUITING city: Tampa state: Florida zip: 33606 country: United States name: Kiria Almeida-Tamayo, SC role: CONTACT phone: 813-844-8058 email: [email protected] name: Debbie Hoffman, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: West Georgia Cardiology status: RECRUITING city: Carrollton state: Georgia zip: 30117 country: United States name: Justina Okeke, SC role: CONTACT phone: 678-839-7285 email: [email protected] name: Charlie Rouse, MD role: PRINCIPAL_INVESTIGATOR lat: 33.58011 lon: -85.07661 facility: University of Chicago status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Veronica Herzog, SC role: CONTACT phone: 773-834-9794 email: [email protected] name: Gene Kim, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Advocate Illinois Masonic Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60657 country: United States name: Maci Eiber, SC role: CONTACT phone: 773-296-0969 email: [email protected] name: Sorin Danciu, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Advocate Illinois Masonic Health Center status: RECRUITING city: Downers Grove state: Illinois zip: 60515 country: United States name: Debra Heidenreich, SC role: CONTACT phone: 630-352-2338 email: [email protected] name: Sorin Danciu, MD role: PRINCIPAL_INVESTIGATOR lat: 41.80892 lon: -88.01117 facility: Midwest Cardiovascular Center status: RECRUITING city: Naperville state: Illinois zip: 60540 country: United States name: Josilyn Klimek, SC role: CONTACT phone: 630-600-0730 email: [email protected] name: Maria Rosa Costanzo, MD role: PRINCIPAL_INVESTIGATOR lat: 41.78586 lon: -88.14729 facility: Robert J. Dole VA Medical Center status: RECRUITING city: Wichita state: Kansas zip: 67218 country: United States name: Deborah Garner, sc role: CONTACT phone: 316-685-2221 phoneExt: 53352 email: [email protected] name: Freidy Eid, MD role: PRINCIPAL_INVESTIGATOR lat: 37.69224 lon: -97.33754 facility: St. Elizabeth Healthcare status: RECRUITING city: Edgewood state: Kentucky zip: 41017 country: United States name: Cynthia Mulcahy, SC role: CONTACT phone: 859-301-4046 email: [email protected] name: Haree Vongooru, MD role: PRINCIPAL_INVESTIGATOR lat: 39.01867 lon: -84.58189 facility: Cardiovascular Institute of the South status: RECRUITING city: Houma state: Louisiana zip: 70360 country: United States name: Kimberly Lirette, SC role: CONTACT phone: 985-873-5619 email: [email protected] name: Peter Fail, MD role: PRINCIPAL_INVESTIGATOR lat: 29.59577 lon: -90.71953 facility: Cardiovascular Institute of the South status: RECRUITING city: Lafayette state: Louisiana zip: 70503 country: United States name: June Jones, SC role: CONTACT phone: 337-289-8429 email: [email protected] name: Wade May, MD role: PRINCIPAL_INVESTIGATOR lat: 30.22409 lon: -92.01984 facility: University Medical Center New Orleans status: RECRUITING city: New Orleans state: Louisiana zip: 70112 country: United States name: Katasha Washington, SC role: CONTACT phone: 504-702-4704 email: [email protected] name: Frank Smart, MD role: PRINCIPAL_INVESTIGATOR lat: 29.95465 lon: -90.07507 facility: Nebraska Heart Center status: RECRUITING city: Lincoln state: Nebraska zip: 68526 country: United States name: Julie Potter, SC role: CONTACT phone: 402-328-3950 email: [email protected] name: Steven Krueger, MD role: PRINCIPAL_INVESTIGATOR lat: 40.8 lon: -96.66696 facility: VA Southern Nevada Healthcare System status: RECRUITING city: North Las Vegas state: Nevada zip: 89086 country: United States name: Rosalinda Cruz, SC role: CONTACT phone: 702-791-9000 phoneExt: 15575 email: [email protected] name: Marriyam Moten, MD role: PRINCIPAL_INVESTIGATOR lat: 36.19886 lon: -115.1175 facility: Mount Sinai Morningside status: RECRUITING city: New York state: New York zip: 10025 country: United States name: Kathy Idrissi, SC role: CONTACT phone: 646-561-1170 email: [email protected] name: Kiran Mahmood, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: The Mount Sinai Hospital status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Lovelyne Julien, SC role: CONTACT phone: 212-241-1537 email: [email protected] name: Anuradha Lala - Trindade, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: St. Francis Hospital status: RECRUITING city: Roslyn state: New York zip: 11576 country: United States name: Lyn Santiago, SC role: CONTACT phone: 516-562-6763 email: [email protected] name: Rita Jermyn, MD role: PRINCIPAL_INVESTIGATOR lat: 40.79982 lon: -73.65096 facility: Mission Hospital status: RECRUITING city: Asheville state: North Carolina zip: 28803 country: United States name: Josephine Purbrick, SC role: CONTACT phone: 828-412-9149 email: [email protected] name: Vinay Thohan, MD role: PRINCIPAL_INVESTIGATOR lat: 35.60095 lon: -82.55402 facility: Moses H. Cone Memorial Hospital status: RECRUITING city: Greensboro state: North Carolina zip: 27401 country: United States name: Michelle McCart, SC role: CONTACT phone: 336-832-3799 email: [email protected] name: Daniel Bensimhon, MD role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 facility: The Lindner Research Center at The Christ Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45219 country: United States name: Kathryn Gloria, SC role: CONTACT email: [email protected] name: Eugene Chung, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: Savi Radesic role: CONTACT phone: 216-445-6916 email: [email protected] name: W.H. Wilson Tang, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: The Ohio State University status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Carina Pannelle role: CONTACT phone: 614-366-8650 email: [email protected] name: Rami Kahwash, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Vanderbilt University Medical Center status: RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Terry Weyand, SC role: CONTACT phone: 615-322-9349 email: [email protected] name: JoAnn Lindenfeld, MD role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: Rio Grande Regional Hospital status: RECRUITING city: McAllen state: Texas zip: 78503 country: United States name: Dina Garcia, SC role: CONTACT phone: 956-632-6054 email: [email protected] name: Norman Ramirez, MD role: PRINCIPAL_INVESTIGATOR lat: 26.20341 lon: -98.23001 facility: Methodist Hospital of San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Maurene Cantu role: CONTACT phone: 210-218-4950 email: [email protected] name: Sachin Gupta, MD role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 facility: University Hospital Samson Assuta Ashdod status: RECRUITING city: Ashdod country: Israel name: Sapir Swisa, SC role: CONTACT name: Alexander Goldman, MD role: PRINCIPAL_INVESTIGATOR lat: 31.79211 lon: 34.64967 facility: Assuta Be'er Sheva Medical Center status: RECRUITING city: Be'er Sheva country: Israel name: Alex Demitriev, SC role: CONTACT name: Amos Katz, MD role: PRINCIPAL_INVESTIGATOR lat: 31.25181 lon: 34.7913 facility: Rambam Medical Center status: RECRUITING city: Haifa country: Israel name: Ludmila Helmer, SC role: CONTACT phone: 972-4-7773475 name: Oren Caspi, MD role: PRINCIPAL_INVESTIGATOR lat: 32.81841 lon: 34.9885 facility: Shaare Zedek Medical Center status: RECRUITING city: Jerusalem country: Israel name: Hadas Barda, SC role: CONTACT phone: 972-2-6666769 name: Tal Hasin, MD role: PRINCIPAL_INVESTIGATOR lat: 31.76904 lon: 35.21633 facility: Galiee Medical Center status: RECRUITING city: Nahariya country: Israel name: Etti Lasri Kadosh, SC role: CONTACT phone: 972-4-9107747 name: Shaul Atar, MD role: PRINCIPAL_INVESTIGATOR lat: 33.00892 lon: 35.09814 facility: Tel Aviv Sourasky (Ichilov) Medical Center status: RECRUITING city: Tel Aviv country: Israel name: Tal Fux, SC role: CONTACT phone: 972-3-6972420 name: Michal Laufer Perl, MD role: PRINCIPAL_INVESTIGATOR lat: 32.08088 lon: 34.78057 facility: Poriya Medical Center status: RECRUITING city: Tiberias country: Israel name: Jannat Mukari, SC role: CONTACT phone: 972-4-6652201 name: Wadi Kinany, MD role: PRINCIPAL_INVESTIGATOR lat: 32.79221 lon: 35.53124 hasResults: False |
<|newrecord|> nctId: NCT06378619 id: CSAPG-50 briefTitle: Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach acronym: MATSEP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-06 date: 2024-04-22 date: 2024-04-22 name: Consorci Sanitari de l'Alt Penedès i Garraf class: OTHER briefSummary: In clinical practice, it is sometimes difficult to establish whether a patient's tremor is due to Parkinson's disease or essential tremor. The distinction is crucial as the health implications differ significantly between the two conditions. Therefore, the present study aims to develop a diagnostic method based on machine learning techniques to help differentiate whether a patient's tremor is due to one condition or the other. To achieve this, 110 patients with tremor, correctly diagnosed with either Parkinson's disease or essential tremor, will participate. They will undergo two diagnostic tests (tapping test and Archimedean spiral) to capture data that can be processed using machine learning techniques. conditions: Tremor conditions: Essential Tremor conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Tapping Test name: Archimedes Spiral measure: Sensitivity measure: Specificity measure: Reliability sex: ALL minimumAge: 45 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf city: Barcelona state: Cataluña zip: 08810 country: Spain name: José Luis Camacho, MD role: CONTACT phone: +34 938960025 email: [email protected] name: Noemí Casaponsa role: CONTACT phone: +34 938960025 phoneExt: 43197 email: [email protected] name: José Luis Camacho, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False |
<|newrecord|> nctId: NCT06378606 id: P.T.REC/012/004907 briefTitle: Effect of Technology on Cognitive Function in Elderly acronym: cogntion overallStatus: RECRUITING date: 2023-07-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-22 date: 2024-04-22 name: Nourhan Hesham Ali class: OTHER name: Cairo University briefSummary: Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly . primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly . whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: cognitive therapy measure: Cognitive functions assessment measure: Quality of life survey sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Nour Ali status: RECRUITING city: Cairo state: Giza zip: 12511 country: Egypt name: Nour Ali, master role: CONTACT phone: 01156860154 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06378593 id: 3HP-2827-102 briefTitle: A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-03 date: 2028-06 date: 2024-04-22 date: 2024-04-22 name: 3H (Suzhou) Pharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. conditions: Solid Tumors With FGFR2 Alterations, Adult studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: 3HP-2827 measure: Dose Escalation Stage- incidence of adverse events (AEs) measure: Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters measure: Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827 measure: Expansion stage -Objective response rate（ORR） measure: Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy. measure: Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Duration of Response (DOR) as assessed by RECIST v1.1 measure: Disease control rate (DCR) as assessed by RECIST v1.1 measure: Progression-free survival (PFS) as assessed by RECIST v1.1 measure: Overall survival (OS) measure: Dose escalation stage - Objective Response Rate (ORR) measure: Expansion Stage- incidence of adverse events (AEs) measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters measure: Expansion Stage -Changes in patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer Core QoL Questionnaire (EORTC QLQ-C30) in patients with advanced solid tumors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Lin Shen, MD role: CONTACT lat: 39.9075 lon: 116.39723 facility: ZhongShan Hospital city: Shanghai state: Shanghai zip: 200123 country: China name: Jia Fan, MD role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06378580 id: LGF22H160084 id: LGF22H160084 type: OTHER_GRANT domain: Zhejiang Provincial Basic Public Welfare Research Program briefTitle: The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma overallStatus: COMPLETED date: 2022-07-01 date: 2023-07-01 date: 2024-04-01 date: 2024-04-22 date: 2024-04-22 name: Luo Cong class: OTHER briefSummary: Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive tumor with a poor prognosis, despite the emergence of chemotherapies, unmet medical needs and limited treatment options still exist for patients with metastatic PDAC (mPDAC). Surufatinib is a small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor (VEGFR) 1, 2, 3, fibroblast growth factor receptor 1 (FGFR1), and colony stimulating factor 1 receptor (CSF-1R), and ex vivo experiments have demonstrated its effect on PC models. |
A retrospective analysis of patients with PDAC who underwent surufatinib at Zhejiang Cancer Hospital (Hangzhou,China) from July 2022 to July 2023.The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing surufatinib in the investigators' hospital. conditions: Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 72 type: ACTUAL name: Surufatinib combine immune checkpoint inhibitor name: AG/FOLFIRINOX measure: Median progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Province Cancer Hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06378567 id: HCD J8923 briefTitle: A Study to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-22 date: 2024-04-22 name: The Water Street Collective class: INDUSTRY name: British American Tobacco (Investments) Limited name: HCD Research briefSummary: A home placement, randomized, double blind, placebo-controlled, study to determine the effect of dietary liquid shot beverage products on self-reported measures of sleep, stress and mood on generally healthy participants with current self-reported mild/moderate sleep difficulties (but not clinical insomnia) and mild/moderate stress. conditions: Sleep conditions: Mood conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Dietary supplement liquid shot beverage products measure: Sleep Disturbance measure: Sleep Impairment measure: Insomnia Severity measure: Restorative Sleep measure: Contentedness/Anxiety measure: Profile of Mood States (POMS) measure: Daily Sleep diary sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Sago Atlanta - The Palisades Complex city: Atlanta state: Georgia zip: 30328 country: United States name: Melissa Hall role: CONTACT phone: 770-396-8700 email: [email protected] lat: 33.749 lon: -84.38798 hasResults: False |
<|newrecord|> nctId: NCT06378554 id: IRB00111227 briefTitle: Cereset Research for Performance Improvement in a Hospital Nursing Unit overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: Wake Forest University Health Sciences class: OTHER name: Susanne Marcus Collins Foundation, Inc. briefSummary: The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation. conditions: Health Personnel conditions: Stress conditions: Anxiety conditions: Job Performance conditions: Insomnia conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Cereset Research measure: Percent of ortho trauma unit staff who complete Cereset intervention sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Dawn C Higgins role: CONTACT phone: 336-716-9447 email: [email protected] lat: 36.09986 lon: -80.24422 hasResults: False |
<|newrecord|> nctId: NCT06378541 id: SDR 21-267 briefTitle: Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE) acronym: Project HOPE overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2028-10-31 date: 2028-10-31 date: 2024-04-22 date: 2024-04-22 name: VA Office of Research and Development class: FED briefSummary: This study will test whether a new intervention, Virtual Hope Box Enhanced Facilitation (VHB-EF), reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization. Additionally, this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings. conditions: Suicide Prevention conditions: Suicide Attempt conditions: Suicidal Ideation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 928 type: ESTIMATED name: Virtual Hope Box Enhanced Facilitation name: Enhanced Usual Care measure: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] and medical chart review) measure: Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]) measure: Self-efficacy to resist a future suicide attempt (measured by the Self-Efficacy to Avoid Suicidal Action [SEASA] scale) measure: Ability to cope with stressful situations (measured by the Coping Self-Efficacy [CSE] scale) measure: Reasons to live (measured by the Brief Reasons for Living Inventory [BRFL]) measure: Depression symptoms (measured by the Patient Health Questionnaire [PHQ-9]) measure: Mental Health Treatment Utilization (measured by the Treatment Services Review [TSR]) measure: Demographics measure: Borderline personality disorder features (measured by the Personality Assessment Inventory-Borderline Features Scale [PAI-BOR]) measure: Alcohol misuse (measured by the Alcohol Use Identification Test [AUDIT]) measure: Drug use (measured by the Drug Abuse Screening Test [DAST-10]) measure: Anxiety (measured by the Generalized Anxiety Disorder 7 [GAD-7]) measure: Coping strategies (measured by the Brief-COPE scale) measure: Virtual Hope Box (VHB) frequency measure: VHB app beliefs, usage, and treatment satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Ann Arbor Healthcare System, Ann Arbor, MI city: Ann Arbor state: Michigan zip: 48105-2303 country: United States name: Fatima Makki, MPH MSW role: CONTACT phone: 734-845-3623 email: [email protected] name: Courtney L Bagge, PhD MA role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA city: Seattle state: Washington zip: 98108-1532 country: United States name: Mark Reger, PhD role: CONTACT phone: 253-583-3295 email: [email protected] lat: 47.60621 lon: -122.33207 hasResults: False |
<|newrecord|> nctId: NCT06378528 id: 2023-1706 id: Protocol Version Jan 2024 type: OTHER domain: UW Madison id: A538900 type: OTHER domain: UW Madison briefTitle: Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP) overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-22 date: 2024-04-22 name: University of Wisconsin, Madison class: OTHER briefSummary: The objectives of this study are to investigate the feasibility, tolerability, and efficacy of repeated ketamine-assisted psychotherapy sessions in adolescents with severe posttraumatic stress disorder. The study will enroll adolescents with a current diagnosis of posttraumatic stress disorder (PTSD) to complete three intravenous ketamine administrations immediately prior to a psychotherapy session over the span of six weeks. All participants will complete an initial set of preparatory sessions, and each dosing session will be followed by three integration sessions. Finally, participants will complete 7 nights of at-home sleep recordings. The investigators hypothesize that this protocol will be well-tolerated by adolescents and that patients will experience decreases in PTSD symptom severity at follow-up. conditions: Posttraumatic Stress Disorder studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single group, open label, pilot study primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Ketamine name: SmartSleep EEG recording headband measure: Summary of Adverse Events Attributable to Ketamine Administration measure: Number of Participants Adhering to the Study Protocol measure: Number of Visits Completed Throughout the Study Duration measure: Changes in PTSD symptom severity as measured by the Clinician Administered PTSD Scale Child/Adolescent Version (CAPS-CA) measure: Exploratory Measurements: Change waveform recorded with Philips SmartSleep headband, measured in Hz sex: ALL minimumAge: 15 Years maximumAge: 17 Years stdAges: CHILD facility: University of Wisconsin city: Madison state: Wisconsin zip: 53705 country: United States name: Sara Heyn, JD, PhD role: SUB_INVESTIGATOR name: Stephanie Jones, PhD role: SUB_INVESTIGATOR name: Steven Garlow, MD, PhD role: SUB_INVESTIGATOR name: Paul Hutson, PharmD role: SUB_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False |
<|newrecord|> nctId: NCT06378515 id: Glymphactive briefTitle: Physical Activity, Sleep and Brain Health Based on the Glymphatic System overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-12 date: 2024-04-22 date: 2024-04-22 name: University of Valencia class: OTHER name: University of Oulu briefSummary: This study is aiming to analyze the impact of physical activity on neurohydrodynamics and glymphatic activity on young adults. This study is designed as a multicenter descriptive observational study with information collection at two different times: before performing a short exercise routine and during its performance using a wearable wireless device Glymphometer. conditions: Brain Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 77 type: ESTIMATED name: Physical activity, postural changes and cognitive tasks measure: Brain health measure: Physical activity (habitual) measure: Sleep duration measure: Sleep Quality measure: Chronotype measure: Self-reported health status measure: Other variables sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06378502 id: antibiotic-resistence briefTitle: The Effect of Different Antibiotic Protocols on Peri-implant Tissue Health overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2025-12-30 date: 2026-06-30 date: 2024-04-22 date: 2024-04-22 name: Universita degli Studi di Genova class: OTHER briefSummary: The aim of the present project (non-inferiority trial) is to evaluate the effect of different antibiotic strategies (long-span vs. short-span) for implant surgery on peri-implant tissue health, oral microbiome (included resistome) and salivary MiRNomics in healthy patients. conditions: Antibiotic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Amoxicillin Short name: Amoxicillin Long measure: Mean peri-implant bone loss measure: Incidence of biological and technical complications at the implant site measure: implant survival rate measure: Antibiotic sensitivity measure: Peri-implant myco-, microbiome and resistome measure: Salivary miRNomics measure: Adverse reactions measure: Development of a 3D bone model measure: Plaque index (PI) measure: Bleeding on probing (BOP) measure: Peri-implant pocket probing depth (PPD) sex: ALL minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378489 id: 2022-0346-01 briefTitle: The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-01-31 date: 2025-05-31 date: 2024-04-22 date: 2024-04-22 name: University of the Philippines class: OTHER name: Organon briefSummary: Endometrial hyperplasia without atypia is a condition in which the endometrium (the lining of the uterus) becomes abnormally thick. Although endometrial hyperplasia without atypia is not cancer, it can lead to endometrial cancer in 1-3% of women. This disease is treated by giving progestins. The optimal route, dosage and duration of progestin treatment for endometrial hyperplasia has not yet been determined until now. However, several publications have suggested the use of levonorgestrel releasing IUD as first-line treatment for endometrial hyperplasia without atypia. The other common medications used are the oral progestins medroxyprogesterone (MPA) and norethisterone acetate (NETA). |
The etonogestrel implant (Implant NXT) has been approved for contraceptive use by the US FDA in 2006. The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia. Off-label use of the implant for adrnomyosis, endometriosis and chronic pelvic pain has already been described in various studies. However, its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet. The researchers propose to use the etonogestrel implant (Implant NXT) as novel treatment for endometrial hyperplasia without atypia. The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant. conditions: Endometrial Hyperplasia Without Atypia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Etonogestrel implant measure: Rate of (resolution) regression to normal endometrium measure: Endometrial thickness (by ultrasound) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378476 id: 855188 briefTitle: Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment acronym: SUPPORT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-09 date: 2024-04-22 date: 2024-04-24 name: University of Pennsylvania class: OTHER briefSummary: Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are half as likely to receive a transplant and are often excluded from home dialysis. Structural racism creates complex barriers to optimal CKD care, providing an explanation for these findings. The Penn Medicine IMPaCT Community Health Worker (CHW) program is a rigorously tested approach to employ people from local communities to dismantle structural racism within health care systems and improve outcomes for marginalized patients. This trial will innovate by training CHWs to focus specifically on CKD care for minoritized people. The investigators will also train primary care clinicians caring for CKD patients on how to provide trauma-informed care (TIC). The first aim is to determine the feasibility, acceptability, and reach of a clinic-level TIC training to address the needs and concerns of Black and other minoritized patients. The second aim will be to conduct a three arm trial comparing individuals in usual care to individuals randomized to either our tailored CHW intervention in conjunction with clinic-level TIC training or to clinic-level TIC intervention only. The investigators will examine whether patients in the intervention arms have greater improvements in quality of life (primary). The investigators will also explore the impact of the interventions on patient activation, hospitalizations, and ESKD treatment preferences. conditions: Chronic Kidney Diseases conditions: Racism, Systemic conditions: Trauma, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Research coordinators collecting baseline and outcomes data from participants will be blinded to arm. whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: IMPaCT Community Health Worker Program name: Trauma-Informed Care Training measure: Kidney Disease Quality of Life Instrument (KDQOL) measure: Patient Activation Measure measure: All-Cause Hospitalizations measure: Patient preferences for end-stage renal disease treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378463 id: PSY-2324-S-0362 briefTitle: Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI) acronym: HEADDSET+ overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04 date: 2027-04 date: 2024-04-22 date: 2024-04-22 name: University of Groningen class: OTHER name: Stichting Cosis name: Lentis Psychiatric Institute name: GGZ Friesland briefSummary: Seven per cent of patients suffering from severe mental illness (SMI) need long-term intensive treatment and support in a clinical setting or sheltered living. These service users often experience problems on multiple domains, such as persistent complaints as a result of medication resistance, physical health problems and self-care, psychosocial and cognitive dysfunctioning. Cognitive remediation (CR) training is a type of training aimed at improving thinking abilities (cognitive functioning) and daily functioning. However, we don't yet know if CR training can also help people with SMI who need supported housing due to their severe cognitive and daily living problems. In this project, we are investigating whether we can improve daily functioning in this group by using a form of CR training that focuses on learning new cognitive skills and how to use these new skills in everyday life. Additionally, we are exploring whether combining CR training with mild brain stimulation (transcranial Direct Current Stimulation) can enhance the effects of CR training. conditions: Severe Mental Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pragmatic triple-blinded, randomized, sham-controlled trial, following a non-concurrent multiple baseline design, with the participants serving as their own control. Participants will be randomized over two groups: CIRCuiTS +sham tDCS (group 1), or CIRCuiTS + active tDCS (group 2). The trial will start with a first measurement (T0), followed by a waiting period of 16 weeks and a second measurement (T1). The waiting period serves as the control condition (service users are their own control). Next, the participants will be allocated to 16-20 weeks of either CIRCuiTS + sham tDCS or CIRCuiTS + active tDCS. This period of 16-20 weeks is not fixed as it depends upon how fast participants go through the program. This is followed by a third measurement after treatment (T2). There will be a fourth measurement six months after the end of the intervention (T3). primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participants will be randomly assigned to CR + sham tDCS (group 1) or CR + active tDCS (group 2) with a 1:1 allocation as per a computer-generated randomization plan using permuted blocks of random sizes. The block sizes will not be disclosed to ensure concealment. As such, both the researcher as the participant can stay blind to the tDCS treatment condition. Also, the assessors who will do neuropsychological tests are blind to the condition the participant is in and are blind to the type and aim of the treatment. After finishing measurement T2, the participants can indicate if they suspect to have experienced either the real or the sham tDCS treatment. The patients will be informed about the type of treatment they have received when all participants completed measurement T3. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Cognitive remediation + active tDCS name: Cognitive remediation + sham tDCS measure: Independent Living Skills Survey self- and observer-rated questionnaire (ILSS) measure: Goal Attainment Scale (GAS) measure: Controlled Oral World Association Task (COWAT) measure: Trail Making Test (TMT) measure: Digit span (forward & backward) measure: Wechsler Memory Scale - Visual Reproduction I and II measure: Stroop Color and Word Task (SCWT) measure: 15 Word Test (15-WT) measure: Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task measure: Cognitive Failure Questionnaire (CFQ) measure: Self-Evaluation of Negative Symptoms (SNS) measure: DEX self/informant measure: General Self-Efficacy Scale (GSES) measure: Nurses' Observation Scale of Cognitive Abilities (NOSCA) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cosis city: Assen state: Drenthe zip: 9400 AE country: Netherlands name: Liesbeth Brand, MSc role: CONTACT phone: +31682079633 email: [email protected] lat: 52.99667 lon: 6.5625 facility: Lentis city: Zuidlaren state: Drenthe zip: 9470 AC country: Netherlands name: Lisette van der meer, PhD role: CONTACT phone: +31628259303 email: [email protected] lat: 53.09417 lon: 6.68194 facility: GGZ Friesland city: Leeuwarden state: Friesland zip: 8932 PA country: Netherlands name: Sander De Vos, PhD role: CONTACT phone: +31 6 47368400 email: [email protected] lat: 53.20139 lon: 5.80859 hasResults: False |
<|newrecord|> nctId: NCT06378450 id: 2022-23892-31512-2 briefTitle: Dose-Response Effects of Mindfulness Meditation overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-11-30 date: 2024-11-30 date: 2024-04-22 date: 2024-04-24 name: University of Melbourne class: OTHER briefSummary: The goal of this randomized controlled trial is to test for evidence of dose-response effects in a sample of healthy adults with little to no prior experience with meditation. |
The main question it aims to answer is whether larger doses of mindfulness meditation yield greater positive changes in wellbeing than smaller doses. |
Our hypotheses are that (1) larger doses of mindfulness training will yield significantly larger effects, and (2) different doses will be significantly associated with variation in participant engagement, with lower engagement associated with higher doses. |
Researchers will compare each of three dose conditions, 10-min, 20-min, 30-min, against a minimal dose condition of 3-4 min. |
Participants will take a 28-day mindfulness meditation course, with guided audio instructions provided daily throughout the intervention period (excluding one rest day per week). They will also be asked to respond to surveys before, during, and after the intervention. conditions: Well-Being, Psychological conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 860 type: ESTIMATED name: Mindfulness meditation guided practice measure: Psychological wellbeing measure: Psychological Distress measure: Anxiety measure: Depression measure: Nonattachment measure: Trait Mindfulness measure: Decentering measure: Equanimity measure: Repetitive Negative Thoughts measure: Emotional Regulation measure: Attentional Control measure: Emotional Reactivity measure: Social Anxiety measure: Sleep Quality measure: Momentary Mood measure: State Mindfulness measure: Attention measure: Decentering measure: Mindful Attitudes sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378437 id: GLB-001-02 briefTitle: A Study of GLB-001 in Patients With Myeloid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-12-31 date: 2027-12-31 date: 2024-04-22 date: 2024-04-22 name: Hangzhou GluBio Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV/ET, or study participants with MF/LR-MDS/HR-MDS/AML, respectively. Dose expansion (Phase 1c) will be followed to determine the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Approximately 108 study participants may be enrolled in the study. conditions: Polycythemia Vera conditions: Essential Thrombocythemia conditions: Myelofibrosis conditions: Myelodysplastic Syndromes conditions: Acute Myeloid Leukemia conditions: Myeloid Malignancy studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 108 type: ESTIMATED name: GLB-001 measure: Dose-limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Recommended Expansion Doses (RED) measure: Incidence, Relatedness, Seriousness and Severity of Adverse Events (AEs) measure: Recommended Phase 2 Dose (RP2D) measure: Response Assessment in Study Participants With PV measure: Response Assessment in Study Participants With ET measure: Response Assessment in Study Participants With MF measure: Response Assessment in Study Participants With LR-MDS measure: Response Assessment in Study Participants With HR-MDS measure: Response Assessment in Study Participants With AML measure: GLB-001 and GLB-C183-A-2 (diastereoisomer of GLB-001) Pharmacokinetics after Single Administration - AUC0-last measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-24 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-inf measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Cmax measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Tmax measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - T1/2 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Vz/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - CL/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - λz measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Tmax,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cav,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmax,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmin,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - AUC0-tau measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-AUC0-last measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - λz measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Vz/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - CLss/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - T1/2 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [AUC] measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [Cmax] measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-DF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital city: Zhengzhou state: Henan zip: 450003 country: China name: Hu Zhou, MD role: CONTACT phone: 86-0371-65587320 lat: 34.75778 lon: 113.64861 facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300020 country: China name: Lei Zhang, MD role: CONTACT phone: 86-022-23909240 lat: 39.14222 lon: 117.17667 facility: The First Affilicated Hospital, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310003 country: China name: Hongyan Tong, MD role: CONTACT phone: 86-0571-87236114 lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06378424 id: 2023-6/6 briefTitle: The Effectiveness of Local Dry Cold, Hot and Vibration Applications in Peripheral Intravenous Catheterization overallStatus: COMPLETED date: 2023-03-22 date: 2023-03-22 date: 2023-08-23 date: 2024-04-22 date: 2024-04-22 name: Uludag University class: OTHER briefSummary: Aim: The aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults. |
Methods: The study included 120 adults who were randomly selected between March and August 2023. One application group (n=30) received local hot application, one group (n=30) received local cold application, and one (n=30) received local vibration using the Buzzy® device. The applications, to the site of the peripheral intravenous catheterization, lasted one minute. The control group (n=30) the received standard peripheral intravenous catheterization application. The groups' venous dilation was assessed on the vein assessment scale and the level of pain felt during catheterization was assessed using a visual analog scale. conditions: Pain Management conditions: Emergency Unit conditions: Diarrhea conditions: Nausea conditions: Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ACTUAL name: Cold Application name: Heat Application name: Vibration Application measure: pain intensity in mm measure: venous dilation in score measure: procedure duration in sec measure: weight measure: height sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bursa Uludag University Hospital city: Bursa state: Nilüfer country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False |
<|newrecord|> nctId: NCT06378411 id: P109 briefTitle: Development and Application of a Musical Game for Motor Rehabilitation overallStatus: RECRUITING date: 2024-04-04 date: 2024-07 date: 2024-10 date: 2024-04-22 date: 2024-04-22 name: Universidade da Madeira class: OTHER briefSummary: The aim of this study is to develop, adapt a musical game for residents of RAM, and evaluated the usability and correlation between this game with the improvement of motor coordination in short time. conditions: Health People conditions: Survivors of Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Music Game Intervention measure: Motor Coordination measure: Usability sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universidade da Madeira status: RECRUITING city: Funchal country: Portugal name: Yasmim Moniz, Master role: CONTACT phone: +351 968412551 email: [email protected] role: CONTACT email: [email protected] lat: 32.66568 lon: -16.92547 hasResults: False |
<|newrecord|> nctId: NCT06378398 id: UMCC 2023.037 id: HUM00247729 type: OTHER domain: University of Michigan id: UMI23-13-01 type: OTHER domain: DCP Protocol Number id: 1UG1CA242632-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1UG1CA242632-01A1 briefTitle: A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-08 date: 2024-04-22 date: 2024-04-22 name: University of Michigan Rogel Cancer Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This trial will obtain biomarker data on the possible preventive effects of omeprazole and low-dose aspirin in colorectal tissue. Persons who have had 5 or more adenomas, 5 or more serrated polyps, or an incompletely removed adenoma or serrated polyp in the colon or rectum are potentially eligible. Before participating in the study, study staff will explain the study and review the consent form. If you are interested and provide consent, study staff will then confirm your eligibility. Once enrolled, participants will take two 20 mg omeprazole tablets and two 81 mg aspirin tablets each day before the first meal each day for 25-45 days. |
The study does involve biopsies of the colorectal tissue before and after taking the study medications. The biopsies are samples of tissue, about the size of a grain of rice, that will be taken from the colon or rectum before and after taking the study medications. This is done during a usual, clinical colonoscopy exam and during one more limited exam, called flexible sigmoidoscopy, that is done for the research study. The flexible sigmoidoscopy requires less preparation. Which procedure comes first depends on what fits best with each participant's clinical scenario. Biopsies of both normal mucosa and polyps (if possible) are collected. conditions: Colorectal Neoplasia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 24 type: ESTIMATED name: Omeprazole name: Aspirin measure: Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum measure: Evaluation of gene expression changes sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Michigan Rogel Cancer Center city: Ann Arbor state: Michigan zip: 48109 country: United States name: Kirsten Tuck role: CONTACT phone: 734-763-1141 email: [email protected] name: Elena Stoffel, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Kebire Gofar role: CONTACT email: [email protected] name: Peter Stanich, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False |
<|newrecord|> nctId: NCT06378385 id: DevelopmentCEOAS briefTitle: Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-12-20 date: 2024-04-22 date: 2024-04-25 name: University of Nove de Julho class: OTHER briefSummary: Premature, non-physiological tooth wear in childhood has numerous repercussions for oral health. This is a growing problem with multifactorial causes and associated with the current lifestyle. The aim of the present study was the development and determination of content validity of the Childhood Early Oral Aging Syndrome (CEOAS) index for the primary dentition as a diagnostic and epidemiological survey tool considering the current changes found in this population. conditions: Aging studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 6 type: ESTIMATED name: Childhood Early Oral Aging Syndrome index measure: Development of CEOAS index measure: Validation of CEOAS index sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidade Metropolitana de Santos - UNIMES city: Santos state: São Paulo zip: 11045-002 country: Brazil lat: -23.96083 lon: -46.33361 hasResults: False |
<|newrecord|> nctId: NCT06378372 id: ETICA-ULE-064-2023 briefTitle: How Does Pianistic Musical Training Influence the Development of Alzheimer's Disease? overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-08-01 date: 2025-06-01 date: 2024-04-22 date: 2024-04-22 name: David Franco Castellanos class: OTHER name: Jesús Ángel Seco Calvo name: Javier Tejada Garcia briefSummary: The goal of this clinical trial is to learn about and describe how pianistic training influences the development of Alzheimer's disease. |
The key question is: Can pianistic practice influence the development of Alzheimer's disease? |
Participants will receive piano lessons for 4 weeks (20 sessions) and we will evaluate the evolution of the different parameters described by the tests carried out. conditions: Dementia of Alzheimer Type conditions: Dementia conditions: Dementia, Vascular conditions: Dementia, Mixed conditions: Dementia Frontal conditions: Dementia With Lewy Bodies conditions: Cognitive Decline conditions: Neurologic Disorder conditions: Neurologic Dysfunction conditions: Neurologic Deficits studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: An intervention based on teaching the piano in an individualized way primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Music therapy based on piano learning measure: State of global deterioration measure: Minimental Test measure: RDRS-2 Rapid Disability Assessment Scale measure: MONTREAL COGNITIVE ASSESSMENT (MOCA) measure: WAIS-IV measure: Behavioral disorders: BEHAVE-AD measure: NPI - CUMMINGS measure: Evaluation of the caregiver's burden (Zarit test) sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad de León city: León state: Castilla Y León zip: 24004 country: Spain lat: 42.60003 lon: -5.57032 hasResults: False |
<|newrecord|> nctId: NCT06378359 id: IDIM-2023-32364 briefTitle: Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients overallStatus: RECRUITING date: 2024-01-29 date: 2025-12-31 date: 2026-12-31 date: 2024-04-22 date: 2024-04-22 name: University of Minnesota class: OTHER briefSummary: The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent. |
The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap. |
The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome. conditions: Staphylococcus Aureus Colonization conditions: Surgical Site Infections conditions: Healthcare Associated Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Screening and decolonization for SA carriers with the 3 drug bundle name: No screening for SA name: no screening name: Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening. name: Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening measure: Efficacy in eradicating Staphylococcus aureus (SA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota Medical Center and Clinics status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Pragya Karki, MD role: CONTACT phone: 612-301-6316 email: [email protected] lat: 44.97997 lon: -93.26384 hasResults: False |
<|newrecord|> nctId: NCT06378346 id: 2023-077 briefTitle: GU-01: Glycyrrhizin in Prostate Cancer acronym: GU-01 overallStatus: RECRUITING date: 2024-05 date: 2026-03 date: 2026-03 date: 2024-04-22 date: 2024-04-26 name: University of Illinois at Chicago class: OTHER briefSummary: This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer (PCa) who are candidates for surgery (radical prostatectomy) conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Glycyrrhizin name: Glycyrrhizin name: Observation measure: Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration measure: Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy measure: The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). measure: Assessment of plasma GLY levels after GLY administration measure: Assessment of blood sodium levels after GLY administration measure: Assessment of blood potassium after GLY administration measure: Assessment of serum creatinine after GLY administration measure: Assessment of serum testosterone levels after GLY administration measure: Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration measure: Assessment of interleukin-1β (IL-1β) after GLY administration measure: Assessment of Tumor necrosis factor α (TNFα) after GLY administration measure: Assessment of interleukin 6 (IL-6) after GLY administration measure: Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration measure: Assessment of Hepatocyte Growth Factor (HGF) after GLY measure: Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY measure: Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration measure: Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration measure: Gene expression analysis in tumor specimens obtained before administration of GLY measure: Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Natalie Reizine, MD role: CONTACT phone: 312-996-1581 email: [email protected] name: Omer Qazi, MBBS role: CONTACT phone: 312-413-1069 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False |
<|newrecord|> nctId: NCT06378333 id: 2024-01-023 briefTitle: Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area. acronym: ICAR overallStatus: COMPLETED date: 2022-11-27 date: 2024-01-27 date: 2024-04-15 date: 2024-04-22 date: 2024-04-22 name: University Hospital, Montpellier class: OTHER briefSummary: The study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with UA defined using T hs-cTn measurements The study includes all patients admitted in 2 French university centers with the confirmed diagnostic of UA defined with clinical ischemic symptoms and T hs-cTn concentrations \< 99 percentile (undetectable: \<5ng/l or non-elevated: \<14ng/l), or ≥ 99 percentile but mildly elevated (14-50ng/l) .The primary end-point included major events at 1-year follow-up (total mortality, new ACS, hospitalization for cardiac causes). conditions: Unstable Angina studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 210 type: ACTUAL name: patients who underwent coronary angiography measure: Hospitalisation for of unstable Angina sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Montpellier city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 hasResults: False |
<|newrecord|> nctId: NCT06378320 id: STUDY20240287 briefTitle: eHealth for Breastfeeding Support - the HOTSPOT Trial overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-22 date: 2024-04-22 name: University Hospitals Cleveland Medical Center class: OTHER briefSummary: This is a voluntary research study to test use of a phone app that is intended to support breastfeeding specifically for African American and Black people. This is called a "pilot" study because the app is still in development. The goal of this research is to see if mothers use the app more when they receive text "nudges" to look at it compared to not getting those "nudges". The research project is being conducted by Lydia Furman MD. |
The purpose of the app (which is currently in clickable "wireframe" status, a "pre" app phase) is to support and promote breastfeeding specifically for mothers and fathers/partners who are African American or Black. Other breastfeeding apps have pictures mainly of White or Asian mothers and information that is not oriented toward African American mothers. This app aims to provide accurate and needed breastfeeding information that is culturally attuned. |
Up to 24 participants will be enrolled at UHCMC, including up to 20 mothers. Other participants will include up to 4 African American or Black fathers/partners whose partners are interested in breastfeeding. conditions: Breast Feeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a prospective randomized two arm study for expectant women and a prospective randomized two arm study for fathers/partners. All participants receive access to the wireframe app. Maternal participants will be randomized to nudge or no nudge via text with those in the app "nudge" group receiving questions weekly prior to delivery and biweekly (every 2 weeks) after delivery through 3 months postpartum. The purpose of these "nudges" is to assess whether participants are more likely to access and benefit from the app if they are encouraged to explore it. Father/partner participants will also be randomized to either a nudge or no nudge group with those in the "nudge" group receiving questions weekly for the first two months and then biweekly (every 2 weeks) for another two months. primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: App access and Text message name: App access only measure: Maternal participants app usability score measure: Father/partner participants app usability score measure: Maternal participants app engagement score measure: Father/partner participants app engagement score measure: Maternal participants breastfeeding knowledge at enrollment measure: Maternal participants breastfeeding knowledge after app exposure measure: Father/partner participants breastfeeding knowledge at enrollment measure: Father/partner participants breastfeeding knowledge after app exposure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahuja Rainbow Center for Women and Children city: Cleveland state: Ohio zip: 44103 country: United States lat: 41.4995 lon: -81.69541 facility: Passages, Inc. city: Cleveland state: Ohio zip: 44103 country: United States name: Lydia Furman MD role: CONTACT phone: 216-675-6691 email: [email protected] lat: 41.4995 lon: -81.69541 facility: University Hospital MacDonald Women's Hospital city: Cleveland state: Ohio zip: 44106 country: United States lat: 41.4995 lon: -81.69541 hasResults: False |
<|newrecord|> nctId: NCT06378307 id: CHUBX2022-06 briefTitle: A Transferability Study on the Conditions for a Successful Inclusive Education acronym: TIAP overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-06-30 date: 2025-06-30 date: 2024-04-22 date: 2024-04-22 name: University Hospital, Bordeaux class: OTHER briefSummary: The investigators are conducting a realist evaluation study with a multi-case and qualitative design. The study aims to identify the conditions that promote successful students with disabilities inclusive education at school. This study is nested in the TIAP research (Research to explore the conditions transfer of innovations in the field of disability, with a view to developing a transfer framework). conditions: Inclusive Education studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 114 type: ESTIMATED measure: Effect of inclusive education on children with disabilities autonomy and social participation at school measure: Effect of inclusive education on children with disabilities autonomy and social participation in their proximal living environment (leisures participation) measure: Effect of inclusive education on social participation of families with children with disabilities sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378294 id: UHACoruna briefTitle: Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA) acronym: MACMA overallStatus: RECRUITING date: 2021-04-20 date: 2024-12-31 date: 2029-12-31 date: 2024-04-22 date: 2024-04-25 name: University Hospital A Coruña class: OTHER name: Complejo Hospitalario Universitario de Pontevedra name: Complejo Hospitalario Universitario de Vigo name: Complejo Hospitalario Universitario de Santiago name: Hospital Universitario Lucus Augusti name: Complexo Hospitalario de Ourense briefSummary: Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (IBC) patients undergoing upfront surgery. |
The ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (ALND) in early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial did not included patients treated with mastectomy, and the AMAROS trial only included 17% of mastectomy patients. |
The investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Mastectomy measure: Disease-free survival measure: Axillary recurrence rate measure: Overall survival sex: FEMALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Ferrol status: RECRUITING city: Ferrol state: A Coruña zip: 15402 country: Spain name: EULALIA VIVES role: CONTACT email: [email protected] name: EULALIA VIVES role: PRINCIPAL_INVESTIGATOR name: MANUEL DÍAZ role: SUB_INVESTIGATOR lat: 43.4896 lon: -8.21942 facility: Hospital Universitario Santiago de Compostela status: RECRUITING city: Santiago De Compostela state: A Coruña zip: 15706 country: Spain name: MARÍA EFIGENIA ARIAS role: CONTACT email: [email protected] name: MARÍA EFIGENIA ARIAS role: PRINCIPAL_INVESTIGATOR lat: 42.88052 lon: -8.54569 facility: Hospital Universitario Vigo status: RECRUITING city: Vigo state: Pontevedra zip: 36214 country: Spain name: GONZALO DE CASTRO role: CONTACT email: [email protected] name: GONZALO DE CASTRO role: PRINCIPAL_INVESTIGATOR name: GEORGINA FREIRÍA role: SUB_INVESTIGATOR lat: 42.23282 lon: -8.72264 facility: Hospital Universitario A Coruña status: RECRUITING city: A Coruña zip: 15006 country: Spain name: ALBERTO BOUZÓN role: CONTACT phone: +34690103810 email: [email protected] name: BENIGNO ACEA role: CONTACT phone: +34650482409 email: [email protected] name: MARÍA ALEJANDRA GARCÍA role: SUB_INVESTIGATOR name: ALBERTO BOUZÓN role: PRINCIPAL_INVESTIGATOR name: BENIGNO ACEA role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: Hospital Universitario Lugo status: RECRUITING city: Lugo zip: 27003 country: Spain name: LAURA MUÍÑOS role: CONTACT email: laura.muiñ[email protected] name: LAURA MUÍÑOS role: PRINCIPAL_INVESTIGATOR name: PATRICIA VÁZQUEZ role: SUB_INVESTIGATOR lat: 43.00992 lon: -7.55602 facility: Hospital Universitario Ourense status: RECRUITING city: Orense zip: 32005 country: Spain name: MANUEL GARCÍA role: CONTACT email: [email protected] name: MANUEL GARCÍA role: PRINCIPAL_INVESTIGATOR lat: 42.33669 lon: -7.86407 facility: Hospital Universitario Pontevedra status: RECRUITING city: Pontevedra zip: 36071 country: Spain name: MARÍA TERESA FERNÁNDEZ role: CONTACT email: [email protected] name: MARÍA TERESA FERNÁNDEZ role: PRINCIPAL_INVESTIGATOR lat: 42.431 lon: -8.64435 hasResults: False |
<|newrecord|> nctId: NCT06378281 id: CRSK-3_221381 briefTitle: Testing a New Method to Improve Informed Consent in Prison Research acronym: Spark BATIR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-09-30 date: 2024-04-22 date: 2024-04-24 name: Stéphanie Baggio class: OTHER name: University of Bern name: Leiden University name: School of Health Sciences Fribourg name: University Hospital, Geneva briefSummary: Understanding of informed consent is often limited in prison, due to unique challenges faced by detained people. This study will test a modified "teach-to-goal" informed consent process compared to standard procedures. Conducted within a larger study on psychiatric outcomes, it aims to enhance ethical practices for vulnerable populations. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Modified teach-to-goal informed consent measure: Understanding of the informed consent (binary) measure: Understanding of the informed consent (continuous) measure: Evaluation of the informed consent sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Geneva University Hospitals city: Geneva zip: 1211 country: Switzerland name: Stéphanie Baggio, Prof. role: CONTACT phone: +41316846774 email: [email protected] lat: 46.20222 lon: 6.14569 hasResults: False |
<|newrecord|> nctId: NCT06378268 id: 05/24/DD-BVMD briefTitle: PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study) acronym: ProGanOS overallStatus: RECRUITING date: 2024-04-24 date: 2025-12-31 date: 2026-09-30 date: 2024-04-22 date: 2024-04-26 name: Mỹ Đức Hospital class: OTHER briefSummary: This non-inferiority randomized controlled trial will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.